GUEST COLUMNISTS

• The Endless Possibilities Of Closed-Loop RNA

  The world of RNA now encompasses multiple types of RNA, and circular RNA is a particularly intriguing format.

• Meet Hearables, The Next Revolutionary Medical Devices

  Hearables, in-ear devices that use sensors to monitor health, are poised to become the next revolutionary technology. Jacob Skinner, CEO of U.K.-based wearable technology design and development consultants Thrive Wearables, discusses its possibilities. 

• Qualification Considerations For A “Factory-in-a-Box”

  The cell therapy market is rapidly expanding into a multibillion-dollar industry, but its production is cost-prohibitive due to the limited manufacturing space and number of personnel required, while capacity is not easily scalable and is limited by processing time. Enter the "factory-in-a-box," which can be a game-changer for the industry.
   

• Patenting Antibodies: The 4 Tactics To Use In 2021

  With epitope claims less available post-Amgen v. Sanofi, this article examines four useful approaches that you and your antibody patent lawyer can implement in order to improve your chances of obtaining valid antibody claims with functional attributes.

• RNA Cell Therapy: A New Class of Advanced Therapies

  RNA cell therapy is a new class of advanced therapies now in clinical trials to treat an array of diseases in and beyond oncology.

• What Do Artificial Intelligence And Continuous Validation Have In Common?

  Validation documentation can be reduced by applying automated testing and deployment. This article discusses ISO standards that address risk management, IT alignment with software engineering, opportunities for continuous lifecycle management, and how artificial intelligence (AI) can help.

• The Role Of The Contract Manufacturer Under The EU MDR & IVDR

  As of May 26, 2021, medical device companies must now comply with the EU's Medical Device Regulation (MDR) requirements, and the In Vitro Diagnostics Regulation (IVDR) requirements are effective in May 2022. This article examines the role of the contract manufacturer under these regulations.

• Outlook: Biotech In 2021 & Beyond

  Biopharma companies have responded in an astounding manner to the COVID-19 pandemic through vaccines, therapies, diagnostics, and variant tracking. For those efforts, the industry is seeing some amazing investor awareness, political support, and increased public perception. This article focuses on the U.S., but also includes some worldwide numbers.